Identifying risk factors for infections in children with drug-resistant bacteria
A Retrospective Single Center Study of the Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in PICU Hospitalized Children
This study looks at children in the hospital to see what factors might lead to infections from tough-to-treat bacteria called carbapenem-resistant Enterobacteriaceae.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 536 (estimated) |
| Ages | 29 Days to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT04535661 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on children hospitalized in the pediatric intensive care unit (PICU) at Children's Hospital of Fudan University from January 2018 to December 2019. The aim is to identify risk factors associated with colonization or infection by carbapenem-resistant Enterobacteriaceae (CRE) and to analyze the microbiological characteristics of the CRE isolates. By reviewing clinical and demographic data from electronic health records, the study will categorize patients based on their culture results into non-CRE, CRE colonization, and CRE infection groups. This research addresses a critical gap in understanding the epidemiology of CRE in pediatric patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children who were hospitalized in the PICU of Children's Hospital of Fudan University during the specified time frame.
Not a fit: Patients who were discharged from the PICU within 48 hours or had a positive culture for CRE prior to admission may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention and treatment strategies for infections caused by carbapenem-resistant bacteria in children.
How similar studies have performed: While there is limited data on similar studies specifically in pediatric populations, the investigation of risk factors for drug-resistant infections has shown promise in other settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All children hospitalized in PICU of Children's Hospital of Fudan University from January 2018 to December 2019. Exclusion Criteria: * discharge within 48 hours * patients had a positive culture for CRE before admission * incomplete clinical and demographic data
Where this trial is running
Shanghai, Shanghai Municipality
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Gangfeng Yan — Children's Hospital of Fundan University
- Study coordinator: Gangfeng Yan
- Email: jinyi036@126.com
- Phone: +8615900603082
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.